Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00082745|
Recruitment Status : Recruiting
First Posted : May 19, 2004
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment|
|Cancer Survivor Cardiovascular Complication Malignant Childhood Neoplasm||Other: Laboratory Biomarker Analysis Other: Questionnaire Administration|
I. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.
II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.
III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.
IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls.
V. To explore the role and nature of gene-environment interaction in the development of key adverse events.
DNA and RNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.
|Study Type :||Observational|
|Estimated Enrollment :||8100 participants|
|Official Title:||Key Adverse Events After Childhood Cancer|
|Study Start Date :||March 2004|
|Estimated Primary Completion Date :||January 2100|
Ancillary-Correlative (genetic analysis)
DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Questionnaire Administration
- Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control) [ Time Frame: Up to 1 year ]Epidemiological, clinical and laboratory variables will be tested for their association with key adverse events. McNemar's test for paired data will be used to compare the unmatched general characteristics of cases and controls.
- Frequency of mutations or polymorphisms in specific candidate genes in cases and controls [ Time Frame: Up to 1 year ]Allele frequencies will be estimated by the gene counting method, and the chi-square test will be used to check for departures from Hardy-Weinberg equilibrium.
- Crude disease-exposure [ Time Frame: Up to 1 year ]The crude disease-exposure association will be determined by estimating the OR and its 95% confidence interval (CI). This will be done by univariate conditional logistic regression, to account for the matched design. The significance of the OR will be assessed by the Wald test. Backward stepwise regression procedures will be used to develop the final multivariate model and possible interactions will be examined. The fit of the model will be assessed by the logistic regression diagnostics procedure.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082745
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|Principal Investigator:||Smita Bhatia, MD MPH||Children's Oncology Group|